REDWOOD CITY, Calif., Oct. 2 /PRNewswire/ -- Cellgate Inc., a company developing novel anti-proliferative drugs to combat cancer and other diseases, today announced the initiation of a Phase Ib clinical study of CGC-11047 in patients with advanced solid tumor malignancies or lymphomas.
The Phase Ib study will evaluate the safety and pharmacokinetics of escalating doses of CGC-11047, a polyamine analog drug candidate, in individual combinations with four standard chemotherapeutics -- Gemzar(R) (gemcitabine), Taxotere(R) (docetaxel), Avastin(R) (bevacizumab) or Tarceva(R) (erlotinib) -- all in a single study. Approximately seventy adult patients will be enrolled at ten centers.
"Polyamine analogs such as CGC-11047 represent an interesting approach to halting cellular proliferation associated with cancer," said Dan Von Hoff, M.D., Chief Scientific Officer for U.S. Oncology, Director, Division of Translational Research at TGen and Professor of Medicine at The University of Arizona in Tucson. "This is an innovative study design in which we will evaluate CGC-11047 as part of multiple combination regimens early in the compound's development. There may be clear advantages to this protocol as most chemotherapeutic agents are administered with other drugs, enabling oncologists to find the combinations that provide the greatest benefit in treating a given cancer."
The Phase Ib study is intended to establish a recommended dose for CGC-11047 in each of the combination regimens and to determine a maximum-tolerated dose. In addition, pharmacokinetics and evidence of anti-tumor activity will also be evaluated. CGC-11047 will be administered intravenously weekly over a 28-day cycle. The doses of gemcitabine, docetaxel, bevacizumab or erlotinib will remain fixed according to their respective product labeling.
"We are excited to be undertaking this Phase Ib study to evaluate CGC-11047 in combination with multiple standard chemotherapies," said Edward F. Schnipper, M.D., President and Chief Executive Officer of Cellgate. "CGC-11047 has been well-tolerated in single-agent Phase I studies and has demonstrated promising pre-clinical anti-tumor activity as a single agent. By establishing the safety of CGC-11047 in combination with existing chemotherapeutics among a variety of cancer types -- as well as looking for initial indications of clinical activity -- early on in the clinical development process, we will be better prepared to move into later-stage studies."
Polyamines are cell components considered essential for cell proliferation and differentiation. Cellgate has developed polyamine analogs that target proliferating cells. Cellgate's polyamine analogs are believed to work by binding to nucleic acid, displacing polyamines from their natural binding sites and preventing cell replication. CGC-11047 has been generally well tolerated in prior Phase I clinical studies when tested as a single agent among patients with advanced cancers. In preclinical studies, CGC-11047 has shown promising activity in inhibiting cancer cell growth against multiple tumor cell lines.
Cellgate Inc. is a privately-held company advancing a portfolio of anti-proliferative therapeutics with the potential to address a number of diseases, including cancer, in which uncontrolled cell division is an underlying cause. The company's lead products are advanced polyamine analogs that act by selectively targeting proliferating cells and inducing cell death to halt the progress of disease. Cellgate has two anti-cancer polyamine analog compounds, CGC-11047 and CGC-11093, currently in Phase II and Phase I clinical trials with leading investigators. Cellgate has also established a portfolio of promising anti-proliferative leads, including a novel compound with demonstrated preclinical activity in macular degeneration. For more information about Cellgate, please visit www.cellgate.com .
CONTACT: Edward F. Schnipper, M.D., President and Chief Executive Officerof Cellgate Inc., +1-650-610-7800, or email@example.com; or KarenBergman, +1-650-575-1509, or firstname.lastname@example.org, or Michelle Corral,+1-415-794-8662, or email@example.com, both of BCC Partners, forCellgate Inc.